Apexigen Doses First Patient in Phase 1 Clinical Trial of Its Immuno-oncology Therapeutic Antibody APX005M
Novel agonistic antibody targeting CD40 to be evaluated in solid tumor patients
SAN CARLOS, Calif., June 16, 2015 — a biopharmaceutical company discovering and developing innovative antibody drugs for the treatment of cancer and other life-threatening diseases, announced today the initiation of a Phase 1 clinical trial of APX005M, the company’s lead proprietary anticancer program. APX005M is an immuno-activating monoclonal antibody targeting CD40, a receptor that plays a central role in the regulation of antigen presentation functions and tumor-specific T cell response.
The trial is a Phase 1, open-label dose-escalation study of APX005M in adults with solid tumors that is intended to establish the maximum tolerated dose, the pharmacokinetic profile and the overall safety and tolerability of APX005M. The study will also seek evidence of activation of the immune system in response to treatment and preliminary assessment of clinical response.
“We believe that APX005M has already demonstrated best-in-class potential in preclinical evaluation and could become an essential component in immuno-oncology combinations with immune check point inhibitors, or other immunotherapies,” said Xiaodong Yang, M.D., Ph.D., President and CEO of Apexigen. “Activation and establishment of a specific immune response against cancers is important for tumor eradication and in the creation of tumor-specific memory immune cells that can prevent tumors from recurring. APX005M could play a critical role in activating as well as maintaining the tumor-specific immunity.”
Apexigen, Inc. is a privately held biopharmaceutical company discovering and developing innovative antibody therapeutics for the treatment of life-threatening and difficult-to-treat diseases. Using its proprietary antibody technology platform, Apexigen has discovered a pipeline of product candidates, which are currently at varying stages of development. The lead product candidate, APX005M, is a novel immuno-oncology antibody that stimulates and enhances an immune response against cancer. APX005M was discovered using Apexigen’s proprietary antibody discovery technology, which has been demonstrated to generate antibodies with high affinity, specificity and stability. Apexigen is developing other product candidates in partnership with four leading biopharmaceutical companies in China. In addition, Apexigen has formed strategic partnerships with multi-national pharmaceutical companies, including Janssen Biotech, Alcon Laboratories and Toray Industries to discover first-in-class antibody lead candidates for the partners’ programs. For further information on Apexigen, please visit www.apexigen.com.
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